Trial Outcomes & Findings for A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia (NCT NCT02055157)

NCT ID: NCT02055157

Last Updated: 2021-01-15

Results Overview

A treatment-emergent Adverse Events (TEAE) is any Adverse Events that newly appeared, increased in frequency or worsened in severity following initiation of study drug administration. Serious adverse event (SAE).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Up to Month 6 ± 7 Days

Results posted on

2021-01-15

Participant Flow

This study was conducted at nine study centers in United States, Australia, United Kingdom and France.

Participant milestones

Participant milestones
Measure	Cohort 1 Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Initial 6 Months STARTED	8	8	10	9
Initial 6 Months COMPLETED	7	7	10	8
Initial 6 Months NOT COMPLETED	1	1	0	1
18-month Extension STARTED	7	7	10	8
18-month Extension COMPLETED	6	6	10	8
18-month Extension NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Initial 6 Months Subject discontinued due to NeedlePhobia	0	1	0
Initial 6 Months Adverse Event	0	0	1
Initial 6 Months Consent withdrawn by subject	1	0	0
18-month Extension Investigator decision	0	1	0
18-month Extension Subject discontinued due to NeedlePhobia	1	0	0

Baseline Characteristics

A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=9 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Total n=35 Participants Total of all reporting groups
Age, Continuous	7.3 yrs STANDARD_DEVIATION 1.58 • n=5 Participants	8.3 yrs STANDARD_DEVIATION 2.19 • n=7 Participants	8.0 yrs STANDARD_DEVIATION 1.63 • n=5 Participants	6.9 yrs STANDARD_DEVIATION 1.17 • n=4 Participants	7.6 yrs STANDARD_DEVIATION 1.68 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	24 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Month 6 ± 7 Days

Population: Safety Analysis Population includes all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=9 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Overall Summary of Adverse Events During Initial 6-Month Period Subjects with at Least 1 Reported TEAE	8 Participants	8 Participants	10 Participants	9 Participants
Overall Summary of Adverse Events During Initial 6-Month Period Subjects Least Reported Study Drug-Related TEAE	7 Participants	8 Participants	9 Participants	9 Participants
Overall Summary of Adverse Events During Initial 6-Month Period Subjects with at Least 1 Reported SAE	0 Participants	0 Participants	0 Participants	0 Participants
Overall Summary of Adverse Events During Initial 6-Month Period Subjects Least Reported Study Drug-Related SAE	0 Participants	0 Participants	0 Participants	0 Participants
Overall Summary of Adverse Events During Initial 6-Month Period Subjects Who Died	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Month 25 ± 7 Days

Population: Safety Analysis Population.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=9 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Overall Summary of Adverse Events During Entire Study Period Subjects Least Reported Study Drug-Related TEAE	7 Participants	8 Participants	9 Participants	9 Participants
Overall Summary of Adverse Events During Entire Study Period Subjects with at Least 1 Reported TEAE	8 Participants	8 Participants	10 Participants	9 Participants
Overall Summary of Adverse Events During Entire Study Period Subjects with at Least 1 Reported SAE	1 Participants	0 Participants	1 Participants	1 Participants
Overall Summary of Adverse Events During Entire Study Period Subjects Least Reported Study Drug-Related SAE	0 Participants	0 Participants	0 Participants	0 Participants
Overall Summary of Adverse Events During Entire Study Period Subjects Who Died	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At 6 month (Day 183)

Population: Efficacy Analysis Population includes all subjects who received at least one dose of study treatment and who had post treatment data for any efficacy endpoint in the corresponding period were included in the Efficacy Analysis and Extension Efficacy Analysis population.

Annualized Growth Velocity at Day 183 is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Annualized Growth Velocity (AGV) During Initial 6-Month Baseline	3.755 cm/year Standard Deviation 1.1094	2.891 cm/year Standard Deviation 1.3920	4.044 cm/year Standard Deviation 2.2751	4.492 cm/year Standard Deviation 1.1889
Change From Baseline in Annualized Growth Velocity (AGV) During Initial 6-Month Change from Baseline to Day 183	-0.371 cm/year Standard Deviation 1.5920	1.276 cm/year Standard Deviation 1.4387	2.014 cm/year Standard Deviation 1.9990	2.085 cm/year Standard Deviation 2.1375

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

Annualized Growth Velocity at Day 183 visit is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 3 and 4 Baseline	4.044 cm/year Standard Deviation 2.2751	4.492 cm/year Standard Deviation 1.1889	—	—
Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	1.744 cm/year Standard Deviation 1.7974	1.538 cm/year Standard Deviation 1.3387	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

Annualized Growth Velocity at 1st visit with \>= 12 months on 15ug/kg is assessed on standing height as ((Height at 1st Visit with \>= 12 Months on 15 μg/kg - Height at 1st Visit on 15 μg/kg)/(Date of the 1st Visit with \>= 12 months on 15 μg/kg - Date of at 1st Visit on 15 μg/kg)) x 365.25.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 1 and 2 Switchers Baseline	3.629 cm/year Standard Deviation 1.1586	3.510 cm/year Standard Deviation 0.8327	—	—
Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline at >=12 Months on 15μg/kg	1.846 cm/year Standard Deviation 2.1466	2.245 cm/year Standard Deviation 0.9176	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population

Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 Standard Deviation Scores (SDs) indicate a child's height is no longer within normal height range for average stature children of the same sex and age. Z-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Height Z-Scores Using Centers for Disease Control and Prevention (CDC) Reference Standard During Initial 6-Months Baseline	-6.056 z score Standard Deviation 0.6331	-5.145 z score Standard Deviation 0.8530	-4.613 z score Standard Deviation 1.1355	-5.193 z score Standard Deviation 0.7486
Change From Baseline in Height Z-Scores Using Centers for Disease Control and Prevention (CDC) Reference Standard During Initial 6-Months Change from Baseline to Day 183	-0.008 z score Standard Deviation 0.1788	0.078 z score Standard Deviation 0.1440	0.229 z score Standard Deviation 0.1505	0.265 z score Standard Deviation 0.1869

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age. Z-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 3 and 4 Baseline	-4.613 z score Standard Deviation 1.1355	-5.193 z score Standard Deviation 0.7486	—	—
Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	0.788 z score Standard Deviation 0.2842	0.896 z score Standard Deviation 0.3010	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age. Z-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	0.520 z score Standard Deviation 0.2950	0.259 z score Standard Deviation 0.1887	—	—
Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 1 and 2 Switchers Baseline	-6.064 z score Standard Deviation 0.6932	-4.912 z score Standard Deviation 0.7708	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population

The Upper to Lower Body ratio prior to treatment, at baseline, and through 6 months is assessed on Sitting Height / (Standing Height - Sitting Height)

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper to Lower Body Ratios During Initial 6-Months Baseline	2.094 Ratio Standard Deviation 0.0984	2.027 Ratio Standard Deviation 0.1793	1.911 Ratio Standard Deviation 0.2286	1.962 Ratio Standard Deviation 0.1822
Change From Baseline in Upper to Lower Body Ratios During Initial 6-Months Change from Baseline to Day 183	-0.021 Ratio Standard Deviation 0.0626	0.003 Ratio Standard Deviation 0.0510	-0.024 Ratio Standard Deviation 0.0369	-0.030 Ratio Standard Deviation 0.0811

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 3 and 4 Baseline	1.911 ratio Standard Deviation 0.2286	1.962 ratio Standard Deviation 0.1822	—	—
Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	-0.067 ratio Standard Deviation 0.0451	-0.121 ratio Standard Deviation 0.1058	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population

The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Arm Length to Lower Arm (Forearm) Length Ratio During Initial 6-Months Baseline	1.130 ratio Standard Deviation 0.1168	1.143 ratio Standard Deviation 0.0924	1.130 ratio Standard Deviation 0.1190	1.106 ratio Standard Deviation 0.0816
Change From Baseline in Upper Arm Length to Lower Arm (Forearm) Length Ratio During Initial 6-Months Change from Baseline to Day 183	-0.019 ratio Standard Deviation 0.0623	0.001 ratio Standard Deviation 0.0521	-0.048 ratio Standard Deviation 0.1002	0.003 ratio Standard Deviation 0.0869

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 3 and 4 Baseline	1.130 ratio Standard Deviation 0.1190	1.106 ratio Standard Deviation 0.0816	—	—
Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	0.037 ratio Standard Deviation 0.0673	-0.027 ratio Standard Deviation 0.0504	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 1 and 2 Switchers Baseline	2.119 ratio Standard Deviation 0.0812	2.053 ratio Standard Deviation 0.1746	—	—
Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	-0.078 ratio Standard Deviation 0.0452	-0.078 ratio Standard Deviation 0.1271	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Baseline	1.131 ratio Standard Deviation 0.1280	1.114 ratio Standard Deviation 0.0520	—	—
Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	0.009 ratio Standard Deviation 0.0056	-0.004 ratio Standard Deviation 0.1181	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Leg Length (Thigh) / Knee to Heel Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Initial 6-months Baseline	0.672 ratio Standard Deviation 0.0600	0.662 ratio Standard Deviation 0.0585	0.687 ratio Standard Deviation 0.0268	0.691 ratio Standard Deviation 0.0847
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Initial 6-months Change from Baseline to Day 183	-0.002 ratio Standard Deviation 0.0401	-0.006 ratio Standard Deviation 0.0462	0.007 ratio Standard Deviation 0.0411	-0.006 ratio Standard Deviation 0.0810

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 3 and 4 Baseline	0.687 ratio Standard Deviation 0.0268	0.691 ratio Standard Deviation 0.0847	—	—
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	0.010 ratio Standard Deviation 0.0503	-0.033 ratio Standard Deviation 0.1065	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Baseline	0.659 ratio Standard Deviation 0.0541	0.673 ratio Standard Deviation 0.0579	—	—
Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	0.002 ratio Standard Deviation 0.0228	0.006 ratio Standard Deviation 0.0618	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 6 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=10 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=8 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Initial 6-months Baseline	1.089 ratio Standard Deviation 0.1067	1.074 ratio Standard Deviation 0.1350	1.107 ratio Standard Deviation 0.0607	1.061 ratio Standard Deviation 0.1341
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Initial 6-months Change from Baseline to Day 183	0.001 ratio Standard Deviation 0.0774	0.007 ratio Standard Deviation 0.0863	0.034 ratio Standard Deviation 0.1048	0.015 ratio Standard Deviation 0.1571

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 3 and 4 Baseline	1.107 ratio Standard Deviation 0.0607	1.061 ratio Standard Deviation 0.1341	—	—
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	0.014 ratio Standard Deviation 0.0888	-0.012 ratio Standard Deviation 0.1477	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=6 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Baseline	1.080 ratio Standard Deviation 0.1139	1.100 ratio Standard Deviation 0.1447	—	—
Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	-0.020 ratio Standard Deviation 0.0297	0.018 ratio Standard Deviation 0.1602	—	—

SECONDARY outcome

Timeframe: At month 6 (Day 183)

Population: Efficacy Analysis Population Arm span measurement was optional until July 2015. Therefore data was not collected for all subjects for this outcome measure.

The Arm Span to Height Ratio prior to treatment, at baseline, and through 6 months is assessed by Arm Span / Standing Height.

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=2 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 n=4 Participants Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 n=7 Participants Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Arm Span to Height Ratio During Initial 6-months Baseline	0.901 ratio Standard Deviation 0.0189	0.889 ratio Standard Deviation 0.0906	0.913 ratio Standard Deviation 0.0123	0.893 ratio Standard Deviation 0.0284
Change From Baseline in Arm Span to Height Ratio During Initial 6-months Change from Baseline to Day 183	0.012 ratio Standard Deviation 0.0111	-0.005 ratio Standard Deviation 0.0079	0.007 ratio Standard Deviation 0.0063	0.001 ratio Standard Deviation 0.0143

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height.

Outcome measures

Outcome measures
Measure	Cohort 1 n=5 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 n=8 Participants Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 3 and 4 Baseline	0.911 ratio Standard Deviation 0.0119	0.900 ratio Standard Deviation 0.0315	—	—
Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 3 and 4 Change from Baseline to Month 24	0.000 ratio Standard Deviation 0.0123	-0.006 ratio Standard Deviation 0.0290	—	—

SECONDARY outcome

Timeframe: At month 24

Population: Efficacy Analysis Population

The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height. Values are not available for participants in cohort 1 switchers for Change from Baseline to \>=12 Months on 15ug/kg.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 2 Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 3 Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.	Cohort 4 Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months. 18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.
Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 1 and 2 Switchers Baseline	0.881 ratio Standard Deviation 0.0480	—	—	—
Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 1 and 2 Switchers Change from Baseline to >=12 Months on 15ug/kg	-0.014 ratio Standard Deviation 0.0179	—	—	—

Adverse Events

Initial 6-Months Period 2.5 µg/kg.

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Initial 6-Months Period 7.5 µg/kg.

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Initial 6-Months Period 15 µg/kg.

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Initial 6-Months Period 30 µg/kg.

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Extension Period 2.5 µg/kg.

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Extension Period 7.5 µg/kg.

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Extension Period 15 µg/kg.

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Extension Period 30 µg/kg.

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Entire Study Period 2.5 µg/kg.

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Entire Study Period 7.5 µg/kg.

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Entire Study Period 15 µg/kg.

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Entire Study Period 30 µg/kg.

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Initial 6-Months Period 2.5 µg/kg. n=8 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 7.5 µg/kg. n=8 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 15 µg/kg. n=10 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 30 µg/kg. n=9 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Extension Period 2.5 µg/kg. n=7 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 135.4 days.	Extension Period 7.5 µg/kg. n=14 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 83.1 days.	Extension Period 15 µg/kg. n=22 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 464.7 days.	Extension Period 30 µg/kg. n=8 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 546.4 days.	Entire Study Period 2.5 µg/kg. n=8 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 298.8 days.	Entire Study Period 7.5 µg/kg. n=15 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 175.5 days.	Entire Study Period 15 µg/kg. n=22 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 549.6 days.	Entire Study Period 30 µg/kg. n=9 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 650.9 days.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Congenital, familial and genetic disorders Thyroglossal cyst	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.

Other adverse events

Other adverse events
Measure	Initial 6-Months Period 2.5 µg/kg. n=8 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 7.5 µg/kg. n=8 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 15 µg/kg. n=10 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Initial 6-Months Period 30 µg/kg. n=9 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.	Extension Period 2.5 µg/kg. n=7 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 135.4 days.	Extension Period 7.5 µg/kg. n=14 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 83.1 days.	Extension Period 15 µg/kg. n=22 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 464.7 days.	Extension Period 30 µg/kg. n=8 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 546.4 days.	Entire Study Period 2.5 µg/kg. n=8 participants at risk BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 298.8 days.	Entire Study Period 7.5 µg/kg. n=15 participants at risk BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 175.5 days.	Entire Study Period 15 µg/kg. n=22 participants at risk BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 549.6 days.	Entire Study Period 30 µg/kg. n=9 participants at risk BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 650.9 days.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	37.5% 3/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Nausea	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Dental caries	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	37.5% 3/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Faeces discoloured	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Malpositioned teeth	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Toothache	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Aphthous ulcer	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Gastritis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Gingival bleeding	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Headache	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.7% 5/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 3/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	27.3% 6/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Dizziness	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Presyncope	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Arthropod bite	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Syncope	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Tremor	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Nervous system disorders Sinus headache	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Fall	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Contusion	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Procedural anxiety	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Limb injury	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	28.6% 2/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Thermal burn	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Excoriation	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Joint injury	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Laceration	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Sunburn	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Injury, poisoning and procedural complications Wound	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	44.4% 4/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Vascular disorders Hypotension	37.5% 3/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	40.0% 4/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 5/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	31.8% 7/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Vascular disorders Haematoma	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Vascular disorders Haemorrhage	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Vascular disorders Hypertension	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Vascular disorders Pallor	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Erythema	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Acne	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Skin and subcutaneous tissue disorders Skin striae	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Ear and labyrinth disorders Ear pain	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 2/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 3/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Ear and labyrinth disorders Ear swelling	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Ear and labyrinth disorders Otorrhoea	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Ear and labyrinth disorders Tympanic membrane hyperaemia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Body temperature increased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Eosinophil count increased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Electrocardiogram QT prolonged	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Vitamin D decreased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Blood immunoglobulin E increased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Respiratory rate increased	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Investigations Sleep study abnormal	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Emotional disorder	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Irritability	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Aggression	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Enuresis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Psychiatric disorders Frustration tolerance decreased	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Immune system disorders Drug hypersensitivity	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Immune system disorders Hypersensitivity	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Immune system disorders Seasonal allergy	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Eye disorders Eye pain	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Eye disorders Eye discharge	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Eye disorders Eye inflammation	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Eye disorders Eye irritation	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Eye disorders Hypermetropia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Blood and lymphatic system disorders Lymphadenopathy	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Surgical and medical procedures Ear tube insertion	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Surgical and medical procedures Tooth extraction	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Cardiac disorders Cyanosis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Endocrine disorders Hypothyroidism	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Congenital, familial and genetic disorders Thyroglossal cyst	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site haemorrhage	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site reaction	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	75.0% 6/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	80.0% 8/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	100.0% 9/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	28.6% 2/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	35.7% 5/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	68.2% 15/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	75.0% 6/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	53.3% 8/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	77.3% 17/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	100.0% 9/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site erythema	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	87.5% 7/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	90.0% 9/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	100.0% 9/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	35.7% 5/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 11/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	75.0% 6/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	46.7% 7/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	63.6% 14/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	100.0% 9/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site swelling	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	40.0% 4/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	36.4% 8/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	36.4% 8/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site urticaria	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	44.4% 4/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Pyrexia	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	30.0% 3/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.7% 5/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	31.8% 7/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site bruising	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Pharyngitis streptococcal	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Fatigue	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site pruritus	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Application site erythema	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Cyst	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Influenza like illness	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site discolouration	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Injection site induration	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Malaise	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Medical device site reaction	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
General disorders Pain	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	37.5% 3/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	30.0% 3/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 3/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	31.8% 7/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Ear infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	37.5% 3/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	26.7% 4/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	27.3% 6/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	30.0% 3/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.7% 5/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Otitis media	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	33.3% 3/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Gastroenteritis viral	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 2/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 3/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Viral infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.7% 5/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.7% 5/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Gastroenteritis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Bronchitis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	6.7% 1/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Sinusitis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	9.1% 2/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Conjunctivitis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Influenza	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Otitis externa	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Rhinitis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Acute sinusitis	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Atypical pneumonia	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Croup infectious	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Eye abscess	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Gastrointestinal viral infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Incision site infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Onychomycosis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Pharyngitis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Rash pustular	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Respiratory tract infection	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	10.0% 1/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Scarlet fever	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	11.1% 1/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Tonsillitis	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Tooth abscess	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 1/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Infections and infestations Varicella	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	44.4% 4/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	14.3% 2/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	50.0% 4/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	27.3% 6/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	44.4% 4/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	20.0% 2/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.6% 3/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	18.2% 4/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/10 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	0.00% 0/7 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	7.1% 1/14 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	25.0% 2/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	12.5% 1/8 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	13.3% 2/15 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	4.5% 1/22 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.	22.2% 2/9 • Up to Month 25 ± 7 Days Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period. Extension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.

Additional Information

Alice Hunstman-Labed

BioMarin Pharmaceutical Inc.

Phone: +44 207 4203392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place